Betamethasone Dipropionate
- Product NDC
- 51672-1317
- 11-digit product format
- 516721317
- Labeler code
- 51672
- Product ID
- 51672-1317_c6803523-be80-4491-b882-4a94513be731
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betamethasone Dipropionate
- Dosage form
- OINTMENT, AUGMENTED
- Route
- TOPICAL
- Labeler
- Taro Pharmaceuticals U.S.A., Inc.
- Application
- ANDA076753
- Marketing category
- ANDA
- Marketing start
- 2004-10-12
- Marketing end
- 0000-00-00
- Substance
- BETAMETHASONE DIPROPIONATE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 51672-1317 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 51672-1317 | 51672-1317-1 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 51672-1317 | 51672-1317-3 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 51672-1317 | 51672-1317-5 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51672-1317-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51672-1317-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51672-1317-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 51672-1317-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 51672-1317-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 51672-1317-3 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076753-001 | BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | 2004-10-12 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | 2004-10-12 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | 2004-10-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | 2004-10-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | 2004-10-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A076753-001 | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED / TOPICAL | AB | 2004-10-12 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A076753-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076753-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076753-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076753-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076753-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076753-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076753-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076753-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076753-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076753-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076753-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076753-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076753-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076753-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076753-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076753-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076753-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076753-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076753-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076753-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076753-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076753-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076753-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076753-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076753-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076753-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A076753-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A076753-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076753-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076753-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076753-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076753-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A076753-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A076753-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076753-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A076753-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A076753-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A076753-001 | AB | 1 | cb3db0bc1861… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-1317-1 | GM - Gram | 51672-1317 | 13144d3a-b067-433c-9e61-bac839dcd6b8 | 1 | 2012-07-24 |
| 51672-1317-3 | GM - Gram | 51672-1317 | 2edab7bc-335d-4344-9cdc-23a00ee715b1 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Betamethasone Dipropionate | ACTIVE INGREDIENT | 826Y60901U | BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.] | 6 | |
| Betamethasone | ACTIVE MOIETY | 9842X06Q6M | BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.] | 6 | |
| petrolatum | INACTIVE INGREDIENT | 4T6H12BN9U | BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.] | 6 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.] | 6 | |
| propylene glycol stearate | INACTIVE INGREDIENT | MZM1I680W0 | BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.] | 6 | |
| white wax | INACTIVE INGREDIENT | 7G1J5DA97F | BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.] | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51672-1317 | BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.] | 8 | Legacy NDC | 20241222_a8d9fa54-8715-4e03-ae27-17b26f97e23e.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51672-1317-1 | 51672131701 | 1 TUBE in 1 CARTON (51672-1317-1) > 15 g in 1 TUBE | 1 tube | 2004-10-12 | 0000-00-00 | No | No | Current |
| 51672-1317-3 | 51672131703 | 1 TUBE in 1 CARTON (51672-1317-3) > 50 g in 1 TUBE | 1 tube | 2004-10-12 | 0000-00-00 | No | No | Current |
| 51672-1317-5 | 51672131705 | 5 g in 1 TUBE (51672-1317-5) | 5 g | 2004-10-12 | 0000-00-00 | No | No | Current |