ZANTAC
- Product NDC
- 52565-101
- 11-digit product format
- 525650101
- Labeler code
- 52565
- Product ID
- 52565-101_f893211b-dae4-417b-8d5a-e4f54d0d3833
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ranitidine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Teligent Pharma, Inc.
- Application
- NDA019090
- Marketing category
- NDA
- Marketing start
- 2017-08-23
- Marketing end
- 0000-00-00
- Substance
- RANITIDINE HYDROCHLORIDE
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
| 7f54af34-be54-4c3c-894f-78df6452d747 | Product name | 3 | 20190703 |
| ccf8541e-b7dc-e6ba-06c9-15bf143a7850 | Product name | 5 | 20190611 |
| 05700d9e-ea6f-4aab-b0ed-1488f1d85d7b | Product name | 1 | 20180904 |
| 2f9d4e5c-e179-490e-8c43-f19e1e0ca228 | Product name | 1 | 20160720 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52565-101-25 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-c126-a426-e053-dadaa90af4c2 | ZANTAC ® (ranitidine) Injection Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52565-101-25 | ZANTAC | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | 5 | |
| 52565-101-25 | ZANTAC | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52565-101-01 | ML - Milliliter | 52565-101 | 9fcbb830-8e73-497a-bf27-fd9a5886f9f8 | 1 | 2017-03-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 104084 | Zantac 25 MG/ML Injectable Solution | PSN | c1b12354-9409-4e76-bcdc-024c190d6583 | 5 |
| 1859554 | Zantac 50 MG in 2 ML Injection | PSN | c1b12354-9409-4e76-bcdc-024c190d6583 | 5 |
| 1859554 | 2 ML ranitidine 25 MG/ML Injection [Zantac] | SBD | c1b12354-9409-4e76-bcdc-024c190d6583 | 5 |
| 104084 | ranitidine 25 MG/ML Injectable Solution [Zantac] | SBD | c1b12354-9409-4e76-bcdc-024c190d6583 | 5 |
| 1859553 | 2 ML ranitidine 25 MG/ML Injection | SCD | c1b12354-9409-4e76-bcdc-024c190d6583 | 5 |
| 312772 | ranitidine 25 MG/ML Injectable Solution | SCD | c1b12354-9409-4e76-bcdc-024c190d6583 | 5 |
| 1859554 | 2 ML Zantac 25 MG/ML Injection | SY | c1b12354-9409-4e76-bcdc-024c190d6583 | 5 |
| 312772 | ranitidine (as ranitidine HCl) 25 MG/ML Injectable Solution | SY | c1b12354-9409-4e76-bcdc-024c190d6583 | 5 |
| 1859553 | ranitidine (as ranitidine HCl) 50 MG per 2 ML Injection | SY | c1b12354-9409-4e76-bcdc-024c190d6583 | 5 |
| 104084 | Zantac 25 MG/ML Injectable Solution | SY | c1b12354-9409-4e76-bcdc-024c190d6583 | 5 |
| 1859554 | Zantac 50 MG per 2 ML Injection | SY | c1b12354-9409-4e76-bcdc-024c190d6583 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 52565-101-25 | 52565010125 | 25 in 1 CARTON | Historical |