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NDC 50268-0721-15 Ranitidine 150 mg/1 Details
Ranitidine 150 mg/1
Ranitidine is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by AvPAK. The primary component is RANITIDINE HYDROCHLORIDE.
Product Information
| NDC | 50268-0721 |
|---|---|
| Product ID | 50268-721_89175238-3add-22cd-e053-2a95a90ad3f0 |
| Associated GPIs | 49200020100305 |
| GCN Sequence Number | 011673 |
| GCN Sequence Number Description | ranitidine HCl TABLET 150 MG ORAL |
| HIC3 | Z2D |
| HIC3 Description | HISTAMINE H2-RECEPTOR INHIBITORS |
| GCN | 10200 |
| HICL Sequence Number | 004520 |
| HICL Sequence Number Description | RANITIDINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Ranitidine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ranitidine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 150 |
| Active Ingredient Units | mg/1 |
| Substance Name | RANITIDINE HYDROCHLORIDE |
| Labeler Name | AvPAK |
| Pharmaceutical Class | Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210243 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 50268-0721-15 (50268072115)
| NDC Package Code | 50268-721-15 |
|---|---|
| Billing NDC | 50268072115 |
| Package | 50 BLISTER PACK in 1 BOX (50268-721-15) / 1 TABLET in 1 BLISTER PACK (50268-721-11) |
| Marketing Start Date | 2019-05-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 891713fa-e572-371c-e053-2995a90ae88d Details
USE(S)
DO NOT USE
ASK A DOCTOR BEFORE USE IF
◾ had heartburn over 3 months. This may be a sign of a more serious condition.
◾ heartburn with lightheadedness, sweating or dizziness
◾ chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
◾ frequent chest pain
◾ frequent wheezing, particularly with heartburn
◾ unexplained weight loss
◾ nausea or vomiting
◾ stomach pain
STOP USE AND ASK DOCTOR IF
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)
◾ do not chew tablet (for cool mint tablets only)
◾ children under 12 years: ask a doctor
OTHER INFORMATION
INACTIVE INGREDIENTS
For 150 mg:croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,talcum, titanium dioxide
For 150 mg cool mint:acacia, croscarmellose sodium, FD&C Blue No. 1,magnesium stearate, menthol, microcrystalline cellulose,polyethylene glycol, polyvinyl alcohol, talcum,
titanium dioxide
INGREDIENTS AND APPEARANCE
| RANITIDINE
ranitidine tablet |
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| Labeler - AvPAK (832926666) |