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Doxycycline Hyclate 100 mg Tablet, 44,444-count — NDC 0591-5553-00 (Billing 00591-5553-00)

by Actavis Pharma, Inc. · 44444 TABLET in 1 BOX

This is a package of 44,444 tablets of Doxycycline Hyclate 100 mg Tablet from Actavis Pharma, Inc., marketed since Feb 1983 and currently FDA-listed.

NDC 00591-5553-00
🏷️ FDA NDC (as labeled) 0591-5553-00 billing pads the labeler segment with a zero
This package
Contains44,444-count Pack sizes4 compare ↓
Product page 00591-5553-05 Also comes in: 50 tablets 0591-5553-50 500 tablets 0591-5553-05 53340 tablets 0591-5553-77
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0591-5553-00 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
0591 labeler · 5553 product · 00 package
Package marketed since
Feb 2, 1983
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0591555300 0
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Doxycycline Hyclate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 29, 2025 — Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. (Acella Pharmaceuticals, LLC) · FDA recall D-0014-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0591-5553-00
Product NDC 0591-5553
11-digit billing NDC 00591555300
SPL Set ID 7e06aca6-93af-4511-b92e-50ae1818e0ac
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1983-02-02
Dosage form TABLET
Substance DOXYCYCLINE HYCLATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 04000020100310
GPI class Doxycycline Hyclate
GCN Seq No 009223
GCN 40360
HICL code 004013
Ingredient (HICL) Doxycycline Hyclate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1C
Therapeutic class — specific (HIC3) Tetracycline Antibiotics
AHFS code 08:12.24.00
AHFS class Tetracycline Antibiotics
FDB label name DOXYCYCLINE HYCLATE 100 MG TAB
FDB brand name Doxycycline Hyclate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009223
  • GCN: 40360
  • GPI-14 (Medi-Span): 04000020100310
  • HICL (First Databank): 004013
  • AHFS class code: 08:12.24.00
Why two NDCs? The FDA registers this code as 0591-5553-00 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00591-5553-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name DOXYCYCLINE HYCLATE 100 MG TAB Ingredient Doxycycline Hyclate
📗 Our plain-language guide HelloPharmacist
  • It is an antibiotic for bacterial infections such as rickettsial infections, sexually transmitted infections, respiratory tract infections and eye infections. Some products are als...
  • Take it exactly as your prescriber and label say. Swallow capsules with a full glass of water and avoid taking them right before lying down. For one capsule product, take it at lea...
  • Diarrhea, nausea, vomiting, stomach upset and loss of appetite are the most common. You may also sunburn much more easily, so cover up and avoid tanning beds. Call me or your docto...
  • Call right away for severe or watery diarrhea, a blistering or peeling rash, headache with vision changes, trouble swallowing, or signs of an allergic reaction. Diarrhea can show u...
📖 Read our full Doxycycline guide →
7
Nutrient depletion considerations

Doxycycline Hyclate may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Doxycycline Hyclate nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 50 tablets 500 tablets 53340 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00591-5553-05 0591-5553-05 Main listing 500 TABLET in 1 BOTTLE, PLASTIC $0.1180 / ea $59.00 1990-01-01 — Active
00591-5553-50 0591-5553-50 50 TABLET in 1 BOTTLE, PLASTIC $0.1180 / ea $5.90 1990-01-01 — Active
00591-5553-00 You're viewing this 44444 TABLET in 1 BOX — — — — Active
00591-5553-77 0591-5553-77 53340 TABLET in 1 CONTAINER — — — — Active

You're viewing one of 4 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 500 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 44,444-count package — 44444 tablet in 1 box.
How does this package differ from NDC 00591-5553-50?
Both are Doxycycline Hyclate 100 mg Tablet — the drug itself is identical. This page's package is the 44,444-count one, while NDC 00591-5553-50 is the 50 tablets package.
What NDC number is used to bill for this package of Doxycycline Hyclate 100 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxycycline Hyclate 100 mg 00143-2112-05 Hikma 500 tablets $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 00904-0430-04 Major 1 tablet $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 24658-0310-01 PURACAP 100 tablets $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 27808-0234-01 Cranbury 50 tablets $0.118 AB Availability likely —
Doxycycline 100 mg 42192-0501-05 Acella 500 tablets $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 50268-0279-15 AvPAK 1 tablet $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 53489-0120-02 Sun 50 tablets $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 62135-0626-01 Chartwell 100 tablets $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 62584-0693-21 American 1 tablet $0.118 AB Availability likely —
Doxycycline Hyclate 100 mg 43386-0794-01 Lupin 100 tablets $0.141 AB FDA listed —
Doxycycline Hyclate 100 mgthis 00591-5553-00 Actavis 44444 tablets — — FDA listed —
Doxycycline Hyclate 100 mg 00615-8529-14 NCS 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 33342-0392-05 Macleods 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 40032-0794-01 Novel 100 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 42708-0173-20 QPharma, 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 42806-0310-01 Epic 100 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 46708-0353-20 Alembic 20 tablets — — FDA listed —
Doxycycline Hyclate 100 mg 50090-4981-00 A-S 10 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-6133-00 A-S 10 tablets — AB Discontinued —
Doxycycline Hyclate 100 mg 50090-6134-06 A-S 2 tablets — AB Discontinued —
Doxycycline Hyclate 100 mg 50090-7546-00 A-S 10 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-7547-06 A-S 2 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-7580-00 A-S 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 50090-7800-00 A-S 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 51407-0298-20 Golden 20 tablets — AB FDA listed —
Doxycycline 100 mg 55154-7128-00 Cardinal 1 tablet — AB FDA listed —
Doxycycline Hyclate 100 mg 55154-8079-00 Cardinal 1 tablet — AB FDA listed —
Doxycycline 100 mg 55289-0866-01 PD-Rx 100 tablets — AB FDA listed —
Doxycycline 100 mg 60429-0069-20 Golden 20 tablets — AB Discontinued —
Doxycycline Hyclate 100 mg 60760-0723-20 St. 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 62332-0353-20 Alembic 20 tablets — — FDA listed —
Doxycycline Hyclate 100 mg 64380-0226-02 Strides 500 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 67296-1431-01 RedPharm 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 67296-1456-04 Redpharm 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 67296-2075-02 Redpharm 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 67296-2189-01 Redpharm 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-3466-07 NuCare 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-4836-07 NuCare 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-5265-02 NuCare 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 68999-0626-02 Chartwell 20 tablets — AB FDA listed —
Doxycycline 100 mg 70518-3039-00 REMEDYREPACK 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-3213-01 REMEDYREPACK 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-3214-01 REMEDYREPACK 20 tablets — AB Discontinued —
Doxycycline 100 mg 70518-3363-00 REMEDYREPACK 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-3869-00 REMEDYREPACK 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-4510-00 REMEDYREPACK 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-4544-00 REMEDYREPACK 20 tablets — AB FDA listed —
Doxycycline hyclate 100 mg 70771-1104-00 Zydus 1000 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71205-0697-10 Proficient 10 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-1686-01 Bryant 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-2113-01 Bryant 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-2639-01 Bryant 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-9718-01 Bryant 20 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72162-2402-02 Bryant 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72189-0127-14 direct 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72189-0603-14 Direct_Rx 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72578-0001-01 Viona 100 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0276-14 PD-Rx 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0319-06 PD-Rx 6 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0419-14 PD-Rx 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 82804-0070-14 Proficient 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 82804-0173-14 Proficient 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 83112-0100-00 Health 14 tablets — AB FDA listed —
Doxycycline Hyclate 100 mg 51655-0998-20 Northwind 20 tablets — AB FDA listed —
Doxycycline 100 mg 72789-0597-01 PD-Rx 100 tablets — AB FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1983
On the market since
Feb 1983
📍
2026
Currently FDA-listed
43 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Doxycycline inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerActavis Pharma, Inc.
Labeler code00591
First marketedFeb 1983
Product typeDrug For Further Processing
Portfolio324 products on file

More NDCs from Actavis Pharma, Inc. labeler code 00591

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
500 tablets00591-5553-05 4,424 Rx · $47,348
50 tablets00591-5553-50 1,416 Rx · $14,672
44444 tablets this page00591-5553-00 No Medicaid data
53340 tablets00591-5553-77 No Medicaid data
Drug total (last 4 qtrs): 5,840 Rx · 124,720 units · $62,020 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Doxycycline Hyclate (matched by generic name) — the program that covers self-administered drugs. 29 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Doxycycline Hyclate. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$19.44M
Claims incl. refills
1.9M
Beneficiaries
1.6M
Spend / beneficiary
$12.09
Spend / claim
$10.40
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Actavis Pharma, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Actavis Pharma, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 50 tablets (00591-5553-50), 500 tablets (00591-5553-05), 53340 tablets (00591-5553-77). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Actavis Pharma, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00591-5544-01 · Actavis 00591-5554-01 · Actavis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.