Doxycycline
- Product NDC
- 64380-208
- 11-digit product format
- 643800208
- Labeler code
- 64380
- Product ID
- 64380-208_38deaa0a-0200-49e4-9251-a86dbe2119d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxycycline
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA065070
- Marketing category
- ANDA
- Marketing start
- 2022-09-19
- Substance
- DOXYCYCLINE
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOXYCYCLINE | 150 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | N12000U13O |
| Rxcui | 1649429, 1650142, 1650444, 1652673 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b4321c75-2e87-4d90-9726-9a28fb2293a3 | Product name | 3 | 20260112 |
| 5e99724e-0654-4aec-b7a2-0b9b10e312ee | Product name | 3 | 20250227 |
| d2d36660-68ce-7e7d-0630-ec4b0d859fad | Product name | 6 | 20220921 |
| a239f4dd-cf93-4660-b190-f97d000f249f | Product name | 7 | 20210607 |
| a9d03566-caeb-4466-8021-74599b048880 | Product name | 3 | 20210604 |
| 12750814-20f7-4f35-b5fa-dbc8811ba858 | Product name | 9 | 20201007 |
| 00a5dbaa-1b7d-4e56-be0c-fedc7bbf5ade | Product name | 1 | 20200706 |
| 7b4b06ac-8c50-45f0-9556-293ea558a294 | Product name | 1 | 20180808 |
| 6a5b4392-5ab0-af0d-e0be-47b34e9dbb84 | Product name | 5 | 20171121 |
| 01a4aa74-7e05-63bd-bc10-1b5ceb111371 | Product name | 2 | 20171115 |
| 58b1278c-6dce-49b6-a05e-ea16f389acba | Product name | 1 | 20160620 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64380-208-01 | 2024-04-24 | C162847 | 48780-1 | 1030e365-2864-111a-e063-dadaa90a10e2 | Doxycycline Tablets, USP Rx only |
| 64380-208-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2864-111a-e063-dadaa90a10e2 | Doxycycline Tablets, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64380-208-01 | Doxycycline | 30 in 1 BOTTLE | TABLET | 30 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64380-208-01 | EA - Each | 64380-208 | 5b189237-9989-42df-9fc7-fa00ffba4a12 | 1 | 2022-10-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1650142 | doxycycline monohydrate 100 MG Oral Tablet | PSN | 3b9888a2-ca16-43f7-ab6d-f03188ec2c0d | 6 |
| 1650444 | doxycycline monohydrate 150 MG Oral Tablet | PSN | 3b9888a2-ca16-43f7-ab6d-f03188ec2c0d | 6 |
| 1652673 | doxycycline monohydrate 50 MG Oral Tablet | PSN | 3b9888a2-ca16-43f7-ab6d-f03188ec2c0d | 6 |
| 1649429 | doxycycline monohydrate 75 MG Oral Tablet | PSN | 3b9888a2-ca16-43f7-ab6d-f03188ec2c0d | 6 |
| 1650142 | doxycycline monohydrate 100 MG Oral Tablet | SCD | 3b9888a2-ca16-43f7-ab6d-f03188ec2c0d | 6 |
| 1650444 | doxycycline monohydrate 150 MG Oral Tablet | SCD | 3b9888a2-ca16-43f7-ab6d-f03188ec2c0d | 6 |
| 1652673 | doxycycline monohydrate 50 MG Oral Tablet | SCD | 3b9888a2-ca16-43f7-ab6d-f03188ec2c0d | 6 |
| 1649429 | doxycycline monohydrate 75 MG Oral Tablet | SCD | 3b9888a2-ca16-43f7-ab6d-f03188ec2c0d | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64380-208-01 | 64380020801 | 30 TABLET in 1 BOTTLE (64380-208-01) | 30 tablet | 2022-09-19 | 0000-00-00 | No | No | Current |