Hydrocodone Bitartrate and Homatropine Methylbromide
- Product NDC
- 21695-869
- 11-digit product format
- 216950869
- Labeler code
- 21695
- Product ID
- 21695-869_95828fad-323e-4510-acbf-6d354b25b887
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Homatropine Methylbromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA040613
- Marketing category
- ANDA
- Marketing start
- 2008-02-08
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
- Active strength
- 5 mg/5mL; mg/5mL
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 21695-869 | | I | Inactivated by FDA | | 2026-07-31 |
| excluded package | package | 21695-869 | 21695-869-16 | I | Inactivated by FDA | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A040613-001 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML | SYRUP / ORAL | | | 2008-02-08 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-869-16 | Hydrocodone Bitartrate and Homatropine Methylbromide | 473 mL in 1 BOTTLE | SYRUP | 473 | | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-869 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20110314_95828fad-323e-4510-acbf-6d354b25b887.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 21695-869-16 | 21695086916 | 473 mL in 1 BOTTLE | 473 ml | Historical |