Gianvi Drospirenone and ethinyl estradiol Kit
by Teva Pharmaceuticals USA Inc · 3 BLISTER PACK in 1 PACKAGE (0093-5423-62) / 1 KIT in 1 BLISTER PACK (0093-5423-28)
NDC 00093-5423-62
🏷️ FDA NDC (as labeled)
0093-5423-62
billing pads the labeler segment with a zero
Rx only
Brand
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
0093-5423-62
Product NDC
0093-5423
11-digit billing NDC
00093542362
NCPDP billing unit
EA — each (per item)
Application #
NDA021676
DEA schedule
Non-controlled
Marketing category
NDA AUTHORIZED GENERIC
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Jun 2023)
Dosage form
KIT
GCN Seq No
060548
GCN
26737
HICL code
022026
Ingredient (HICL)
Ethinyl Estradiol/Drospirenone
HIC1 code
G
Therapeutic class — broad (HIC1)
Female Genital System
HIC2 code
G8
Therapeutic class — intermediate (HIC2)
Systemic Antifertility Agents
HIC3 code
G8A
Therapeutic class — specific (HIC3)
Contraceptives,Oral
AHFS code
68:12.00.00
AHFS class
Contraceptives
FDB label name
GIANVI 3 MG-0.02 MG TABLET
FDB brand name
Gianvi
Legend status
F — Federal legend — prescription drug or device
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 0093-5423-62 — 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 → 00093-5423-62. 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.
🏭 Manufacturer & labeler
LabelerTeva Pharmaceuticals USA Inc
Application holderBAYER HEALTHCARE PHARMACEUTICALS INC
FDA applicationNDA021676 (NDA AUTHORIZED GENERIC)
Labeler code00093
Product typeHuman Prescription Drug
Portfolio3 products on file
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.
🩺 Clinical
Label name GIANVI 3 MG-0.02 MG TABLET Ingredient Ethinyl Estradiol/Drospirenone
Patient education
Supplement & herbal interactions
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.
💬 Questions about Drospirenone and ethinyl estradiol?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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.
💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.229 | $0.69 / 3 kit |
| 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. | |
NADAC price history (per ea) — tap or hover for the price & month
▼ Down 44% over the last 15 months.
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Drospirenone and Ethinyl Estradiol 31722-0945-31 | Camber | 1 kit | $0.149 | AB | Availability likely | save 35% |
| Zumandimine 59651-0030-28 | Aurobindo | 1 kit | $0.149 | AB | Availability likely | save 35% |
| Syeda 70700-0115-85 | Xiromed, | 1 kit | $0.149 | AB | Availability likely | save 35% |
| Drospirenone And Ethinyl Estradiol 60505-4897-08 | Apotex | 63 tablets | $0.149 | AB | Availability likely | save 35% |
| Drospirenone And Ethinyl Estradiol 68180-0868-73 | Lupin | 63 tablets | $0.149 | AB | Availability likely | save 35% |
| drospirenone and ethinyl estradiol 68462-0733-29 | Glenmark | 1 kit | $0.149 | AB | Availability likely | save 35% |
| Drospirenone And Ethinyl Estradiol 00378-7300-53 | Mylan | 3 pouches | $0.149 | AB | Availability likely | save 35% |
| Ocella 00555-9131-67 | TEVA | 1 kit | $0.154 | AB | Discontinued | save 33% |
| Drospirenone and ethinyl estradiol 31722-0934-31 | Camber | 1 kit | $0.190 | AB | Availability likely | save 17% |
| Nikki 68180-0886-73 | Lupin | 1 kit | $0.190 | AB | Availability likely | save 17% |
| Vestura 00480-4000-62 | Teva | 72 tablets | $0.190 | AB | Availability likely | save 17% |
| drospirenone and ethinyl estradiol 68462-0720-29 | Glenmark | 1 kit | $0.190 | AB | Availability likely | save 17% |
| Jasmiel 50102-0240-23 | Afaxys | 3 pouches | $0.190 | AB | Availability likely | save 17% |
| Drospirenone and Ethinyl Estradiol 72603-0875-03 | NorthStar | 3 pouches | $0.190 | AB | Availability likely | save 17% |
| Gianvithis 00093-5423-62 | Teva | 1 kit | $0.229 | AB | Discontinued | — |
| Yasmin 50419-0402-03 | Bayer | 1 kit | $4.398 | AB | Availability likely | +1822% |
| Yaz 50419-0405-03 | Bayer | 1 kit | $5.844 | AB | Availability likely | +2454% |
| drospirenone and ethinyl estradiol 71205-0144-28 | Proficient | 1 kit | — | AB | FDA listed | — |
| Lo-Zumandimine 59651-0029-87 | Aurobindo | 1 pouch | — | AB | FDA listed | — |
| Syeda 63629-2335-01 | Bryant | 1 kit | — | AB | FDA listed | — |
| Drospirenone And Ethinyl Estradiol 79929-0019-07 | Naari | 21 tablets | — | AB | FDA listed | — |
| drospirenone and ethinyl estradiol 50090-2494-00 | A-S | 1 kit | — | AB | FDA listed | — |
| drospirenone and ethinyl estradiol 50090-2594-00 | A-S | 1 kit | — | AB | FDA listed | — |
| Drospirenone And Ethinyl Estradiol 67296-2286-03 | Redpharm | 63 tablets | — | AB | FDA listed | — |
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
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
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00093-5423-62 You're viewing this | 3 BLISTER PACK in 1 PACKAGE (0093-5423-62) / 1 KIT in 1 BLISTER PACK (0093-5423-28) | 2016-11-01 | Discontinued by firm |
🧭 About this NDC listing & data coverage
Finished prescription product
Kit / multi-component package
No longer marketed (per FDA listing data)
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| 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) | ✓ Available |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| 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
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 0093-5423-62, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00093-5423-62, written without dashes as 00093542362. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00093-5423-62, the first segment (00093) is the labeler code FDA assigned to Teva Pharmaceuticals USA Inc; the middle segment (5423) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (62) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Teva Pharmaceuticals USA 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.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
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.