temazepam
- Product NDC
- 71610-101
- Requested package NDC
- 71610-101-60
- 11-digit product format
- 716100101
- Labeler code
- 71610
- Product ID
- 71610-101_a5b51b65-39a0-4c0f-97c2-8c91700b5f08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA071457
- Marketing category
- ANDA
- Marketing start
- 1987-04-21
- Marketing end
- 0000-00-00
- Substance
- TEMAZEPAM
- Active strength
- 30 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- 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 package | package | 71610-101 | 71610-101-60 | D | Discontinued by firm | 2026-10-05 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071457-001 | TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | |
| A071457-002 | TEMAZEPAM | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | |
| A071457-003 | TEMAZEPAM | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A071457-001 | AB |
| A071457-002 | AB |
| A071457-003 | AB |
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 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A071457-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A071457-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A071457-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A071457-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A071457-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A071457-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A071457-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071457-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071457-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071457-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071457-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071457-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A071457-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071457-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071457-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071457-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071457-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071457-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071457-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071457-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071457-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071457-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071457-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071457-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071457-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071457-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071457-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071457-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071457-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071457-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071457-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071457-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071457-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A071457-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A071457-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A071457-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071457-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071457-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071457-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071457-001 | AB | 1 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|
| 71610-101-15 | EA - Each | 71610-101 | d858e808-eb8f-466e-aa0a-bdc60de7d041 | 1 | 2018-10-11 |
| 71610-101-20 | EA - Each | 71610-101 | 872cf953-93ec-4a68-8e14-c30d5dab7375 | 1 | 2018-10-11 |
| 71610-101-28 | EA - Each | 71610-101 | 8e20234f-73aa-4584-979c-aabd75b57380 | 1 | 2018-10-11 |
| 71610-101-30 | EA - Each | 71610-101 | 5ab7099b-fa0f-4b93-951d-d26df422f154 | 1 | 2018-10-11 |
| 71610-101-53 | EA - Each | 71610-101 | 7037f83c-ad31-42f0-9689-ed07a844685c | 1 | 2018-10-11 |
| 71610-101-59 | EA - Each | 71610-101 | fd197476-6286-4d74-b7f6-0101c273e18d | 1 | 2018-10-11 |
| 71610-101-60 | EA - Each | 71610-101 | 9fcd19e2-d1be-460d-bf20-60df1a967901 | 1 | 2018-10-11 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 5d83e474-0932-49ae-ad92-ca278cd5f1d5 | 2026-09-09 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 1c08d30d-7c27-a09a-5240-7050771d5cc7 | 2026-09-08 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| Temazepam | TEMAZEPAM | Major Pharmaceuticals | 2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d | 2026-09-01 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | PD-Rx Pharmaceuticals, Inc. | 62379cd5-a314-43eb-a1ee-33997623bfa3 | 2026-08-10 | Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Ascend Laboratories, LLC | 8f54731f-c5b7-492c-acb0-444c5fbb7029 | 2026-08-05 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Preferred Pharmaceuticals Inc. | 7e3fd8fe-fb8a-4577-b540-0e3fefe63627 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 4fe8192a-0f65-4958-8b6d-e87b9fae9eb5 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | bbb6e233-dc6b-43a7-8203-d91421d89921 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | A-S Medication Solutions | 19b2711e-587a-47d2-ab62-d564e7b87195 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | dadc2f66-7fa5-4be4-a9d0-d96e5836f550 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Asclemed USA, Inc. | 254a0273-c0f3-4d2d-b18e-4ab51ba4bc50 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | AvPAK | 08183adb-af12-fcb2-e063-6394a90afea4 | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | ed068e02-a9c6-41ce-beca-83762720663d | 2024-11-01 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 8af67441-167f-4cc8-a498-c4377ba41c6d | 2024-08-30 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | NuCare Pharmaceuticals,Inc. | 62fc08cd-8143-1652-e053-2a91aa0ad7ed | 2024-08-14 | Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 6559dfee-c29b-4707-8b30-8ca14bf23ea0 | 2024-03-22 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 147a51d7-2f8d-43e8-b0ed-a79a2cdfc0a9 | 2024-03-06 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | b2422ca0-2f06-419f-aa0e-88c556b62399 | 2024-01-23 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 1e37d59b-b8be-46ef-8706-fffd563a8c15 | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 0e752dda-f00f-4123-b59f-aa911b897a5a | 2023-12-01 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71610-101-60 | 71610010160 | 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-101-60) | 90 capsule | 2018-07-26 | 0000-00-00 | No | No | Current |