Doxycycline Hyclate
- Product NDC
- 46708-353
- 11-digit product format
- 467080353
- Labeler code
- 46708
- Product ID
- 46708-353_8a6d5c0f-9b8e-444e-882e-8a2264410c02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline Hyclate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA210536
- Marketing category
- ANDA
- Marketing start
- 2020-05-15
- Substance
- DOXYCYCLINE HYCLATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Tetracycline-class Drug [EPC], Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Doxycycline Hyclate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXYCYCLINE HYCLATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19XTS3T51U |
| Rxcui | 1650143, 1652674 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 46708-353-20 | 2023-02-01 | C162847 | 48780-1 | f386c649-f28f-0266-e053-dadaa90a7c1a | Doxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 46708-353-50 | 2023-02-01 | C162847 | 48780-1 | f386c649-f28f-0266-e053-dadaa90a7c1a | Doxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 46708-353-71 | 2023-02-01 | C162847 | 48780-1 | f386c649-f28f-0266-e053-dadaa90a7c1a | Doxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 46708-353-20 | 2023-01-30 | C162847 | 48780-1 | f386c649-f28f-0266-e053-dadaa90a7c1a | Doxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 46708-353-50 | 2023-01-30 | C162847 | 48780-1 | f386c649-f28f-0266-e053-dadaa90a7c1a | Doxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 46708-353-71 | 2023-01-30 | C162847 | 48780-1 | f386c649-f28f-0266-e053-dadaa90a7c1a | Doxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-353-20 | Doxycycline Hyclate | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
| 46708-353-50 | Doxycycline Hyclate | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 3 |
| 46708-353-71 | Doxycycline Hyclate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-353 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 3 package rows | 20230202_24c8472a-dd07-4f84-8bea-20a3f178d119.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-353-20 | 46708035320 | 20 TABLET, FILM COATED in 1 BOTTLE (46708-353-20) | 2020-05-15 | 0000-00-00 | No | No | Current |
| 46708-353-50 | 46708035350 | 50 TABLET, FILM COATED in 1 BOTTLE (46708-353-50) | 2020-05-15 | 0000-00-00 | No | No | Current |
| 46708-353-71 | 46708035371 | 500 TABLET, FILM COATED in 1 BOTTLE (46708-353-71) | 2020-05-15 | 0000-00-00 | No | No | Current |