DOXYCYCLINE HYCLATE
- Product NDC
- 46708-388
- 11-digit product format
- 467080388
- Labeler code
- 46708
- Product ID
- 46708-388_8becf01f-63de-4cf3-881e-94d18fe9274c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DOXYCYCLINE HYCLATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA211744
- Marketing category
- ANDA
- Marketing start
- 2020-06-30
- Substance
- DOXYCYCLINE HYCLATE
- Active strength
- 150 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19XTS3T51U |
| Rxcui | 1649425, 1650446 |
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 |
|---|
| 46708-388-60 | DOXYCYCLINE HYCLATE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 46708-388-91 | DOXYCYCLINE HYCLATE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-388 | DOXYCYCLINE HYCLATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230202_6e587d8d-1a82-4dfa-acea-88704d408f2f.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 |
|---|
| 46708-388-60 | 46708038860 | 60 TABLET, FILM COATED in 1 BOTTLE (46708-388-60) | 2020-06-30 | 0000-00-00 | No | No | Current |
| 46708-388-91 | 46708038891 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-388-91) | 2020-06-30 | 0000-00-00 | No | No | Current |