Doxycycline Hyclate
- Product NDC
- 46708-482
- 11-digit product format
- 467080482
- Labeler code
- 46708
- Product ID
- 46708-482_e1387662-e286-469d-b85f-60344918a17b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxycycline Hyclate
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA213075
- Marketing category
- ANDA
- Marketing start
- 2022-01-04
- 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 | 406524, 434018, 799048, 1423080 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-482-31 | Doxycycline Hyclate | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | | 2 |
| 46708-482-60 | Doxycycline Hyclate | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 2 |
| 46708-482-91 | Doxycycline Hyclate | 1000 in 1 BOTTLE | TABLET, DELAYED RELEASE | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-482 | DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 2 | Current NDC, Legacy NDC, 3 package rows | 20230412_44ac5de1-c0c6-4d58-9a49-b2dae60ea921.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 |
|---|
| 46708-482-31 | 46708048231 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-482-31) | 2022-01-04 | 0000-00-00 | No | No | Current |
| 46708-482-60 | 46708048260 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-482-60) | 2022-01-04 | 0000-00-00 | No | No | Current |
| 46708-482-91 | 46708048291 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-482-91) | 2022-01-04 | 0000-00-00 | No | No | Current |