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NDC 64679-0740-00 RANITIDINE 75 mg/1 Details
RANITIDINE 75 mg/1
RANITIDINE is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Wockhardt USA LLC.. The primary component is RANITIDINE HYDROCHLORIDE.
Product Information
| NDC | 64679-0740 |
|---|---|
| Product ID | 64679-740_f14b4db0-bafe-4847-8600-d88ff3da1acc |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | RANITIDINE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ranitidine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 75 |
| Active Ingredient Units | mg/1 |
| Substance Name | RANITIDINE HYDROCHLORIDE |
| Labeler Name | Wockhardt USA LLC. |
| Pharmaceutical Class | Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078884 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 64679-0740-00 (64679074000)
| NDC Package Code | 64679-740-00 |
|---|---|
| Billing NDC | 64679074000 |
| Package | 60000 TABLET, COATED in 1 DRUM (64679-740-00) |
| Marketing Start Date | 2008-07-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e32f654d-76c6-48d3-96fd-c00e1892ca63 Details
USAGE
WARNINGS
Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers
DO NOT USE
● if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
● with other acid reducers
ASK A DOCTOR BEFORE USE IF YOU HAVE
o frequent wheezing, particularly with heartburn
o frequent chest pain
o stomach pain
o unexplained weight loss
o nausea or vomiting
o had heartburn over 3 months. This may be a sign of a more serious condition.
o heartburn with lightheadedness, sweating or dizziness.
o chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
Stop use and ask a doctor if
o your heartburn continues or worsens
o you need to take this product for more than 14 days
PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
● adults and children 12 years and over:
▪ to relieve symptoms, swallow 1 tablet with a glass of water
▪ to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
▪ can be used up to twice daily (do not take more than 2 tablets in 24 hours)
● children under 12 years: ask a doctor
OTHER INFORMATION
INACTIVE INGREDIENT
QUESTIONS OR COMMENTS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| RANITIDINE
ranitidine tablet, coated |
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| Labeler - Wockhardt USA LLC. (170508365) |
| Registrant - Wockhardt Limited (650069115) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Wockhardt Limited | 676257570 | ANALYSIS(64679-740) , LABEL(64679-740) , MANUFACTURE(64679-740) , PACK(64679-740) | |