Ranitidine
- Product NDC
- 53002-5520
- 11-digit product format
- 530025520
- Labeler code
- 53002
- Product ID
- 53002-5520_8979f9cc-4254-4477-9fcf-75eb8512d59d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranitidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA078542
- Marketing category
- ANDA
- Marketing start
- 2008-11-19
- Marketing end
- 0000-00-00
- Substance
- RANITIDINE HYDROCHLORIDE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53002-5520-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-17f5-f424-e053-dadaa90a57ce | ba0cbe0c-5a1f-4b40-8d9c-2577bfe0a25e |
| 53002-5520-3 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-17f5-f424-e053-dadaa90a57ce | ba0cbe0c-5a1f-4b40-8d9c-2577bfe0a25e |
| 53002-5520-6 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-17f5-f424-e053-dadaa90a57ce | ba0cbe0c-5a1f-4b40-8d9c-2577bfe0a25e |
| 53002-5520-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-17f5-f424-e053-dadaa90a57ce | ba0cbe0c-5a1f-4b40-8d9c-2577bfe0a25e |
| 53002-5520-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-17f5-f424-e053-dadaa90a57ce | ba0cbe0c-5a1f-4b40-8d9c-2577bfe0a25e |
| 53002-5520-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-17f5-f424-e053-dadaa90a57ce | ba0cbe0c-5a1f-4b40-8d9c-2577bfe0a25e |