Pentazocine and naloxone
- Product NDC
- 0591-0395
- Requested package NDC
- 0591-0395-00
- 11-digit product format
- 005910395
- Labeler code
- 0591
- Product ID
- 0591-0395_676211b0-1b6c-426b-ad1a-57bb726fd61c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pentazocine hydrochloride and naloxone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA074736
- Marketing category
- ANDA
- Marketing start
- 1997-05-21
- Substance
- PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Active strength
- 50; .5 mg/1; mg/1
- Pharmacologic classes
- Competitive Opioid Antagonists [MoA], Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|
| unfinished package | package | 0591-0395 | 0591-0395-00 | UNFINISHED | Active or certified unfinished drug listing | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | 5b2001dcd8f5… | 54b53d4dc9e4… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074736-001 | 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 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A074736-001 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET / ORAL | AB | RS | 1997-01-21 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074736-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A074736-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A074736-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074736-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074736-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074736-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074736-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074736-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074736-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074736-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074736-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074736-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074736-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074736-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074736-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A074736-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074736-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A074736-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A074736-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A074736-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A074736-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A074736-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074736-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A074736-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A074736-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A074736-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A074736-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A074736-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A074736-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074736-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A074736-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A074736-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074736-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074736-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074736-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074736-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A074736-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A074736-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074736-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A074736-001 | AB | 1 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pentazocine and naloxone
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PENTAZOCINE HYDROCHLORIDE | 50 mg/1 |
| NALOXONE HYDROCHLORIDE | .5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| A36BXO4PPX | Internal UNII lookup |
| F850569PQR | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312289 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a28450a0-ac93-4235-b9a6-58cdf24773cb | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c955d208-c333-9bd7-be34-d7e12986d44e | Product name | 6 | 20250626 |
| e5f98bfa-66d5-4c3a-b22d-9543d3bee304 | Product name | 1 | 20250204 |
| caa6391e-3db3-c912-335f-61b5fc00aa12 | Product name | 9 | 20240110 |
| 65a3bc34-04ff-4cf1-aad9-c7d92a062f6d | Product name | 1 | 20231003 |
| e951cdf3-f269-4d97-a7d5-c1c3d7283a7d | Product name | 3 | 20230313 |
| ab841ac7-728a-4fc9-be0a-35b96cecbf39 | Product name | 4 | 20230306 |
| f327b80c-8fa2-404b-838a-df3eec141cf2 | Product name | 1 | 20221212 |
| d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119 | Product name | 1 | 20220511 |
| b871fccd-1de6-4c7f-b9e5-045304641ee6 | Product name | 8 | 20220118 |
| 43b1efe2-1425-4b3e-b3a2-57d40f8478b9 | Product name | 1 | 20211026 |
| 4c23a34c-e8fc-424c-8fa0-ee064ba6eaef | Product name | 1 | 20170706 |
| 0b8c7273-1da3-495f-909a-7cf1e96d2361 | Product name | 1 | 20161212 |
| 3df867ed-9d48-45cf-bded-1394beaea0b1 | Product name | 3 | 20161206 |
| 8a245632-e24f-4ccc-b671-995d89c96ebc | Product name | 1 | 20141203 |
| 35c9f831-b55b-8fa5-36b8-614b5af2a2ab | Product name | 1 | 20140508 |
| 96c5169b-5b9d-547d-bf22-d688d91866e4 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0591-0395-01 | Pentazocine and naloxone | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 28 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-0395-01 | EA - Each | 0591-0395 | 9e4e081f-150e-48e2-8c74-5448eba9966c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Pentazocine and naloxone | PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | Actavis Pharma, Inc. | a28450a0-ac93-4235-b9a6-58cdf24773cb | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 074736 ANDA074736 0591-0395 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312289 | pentazocine 50 MG / naloxone 0.5 MG Oral Tablet | PSN | a28450a0-ac93-4235-b9a6-58cdf24773cb | 28 |
| 312289 | naloxone 0.5 MG / pentazocine 50 MG Oral Tablet | SCD | a28450a0-ac93-4235-b9a6-58cdf24773cb | 28 |
| 312289 | naloxone (as naloxone hydrochloride) 0.5 MG / pentazocine (as pentazocine hydrochloride) 50 MG Oral Tablet | SY | a28450a0-ac93-4235-b9a6-58cdf24773cb | 28 |
| 312289 | pentazocine 50 MG / naloxone 0.5 MG Oral Tablet | PSN | 05a17f16-c982-4a54-80cd-079959ab49a7 | 1 |
| 312289 | pentazocine 50 MG / naloxone 0.5 MG Oral Tablet | PSN | 1e2de757-cfe1-4731-93d1-36f80175ef33 | 1 |
| 312289 | naloxone 0.5 MG / pentazocine 50 MG Oral Tablet | SCD | 05a17f16-c982-4a54-80cd-079959ab49a7 | 1 |
| 312289 | naloxone 0.5 MG / pentazocine 50 MG Oral Tablet | SCD | 1e2de757-cfe1-4731-93d1-36f80175ef33 | 1 |
| 312289 | naloxone (as naloxone hydrochloride) 0.5 MG / pentazocine (as pentazocine hydrochloride) 50 MG Oral Tablet | SY | 05a17f16-c982-4a54-80cd-079959ab49a7 | 1 |
| 312289 | naloxone (as naloxone hydrochloride) 0.5 MG / pentazocine (as pentazocine hydrochloride) 50 MG Oral Tablet | SY | 1e2de757-cfe1-4731-93d1-36f80175ef33 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Status |
|---|---|---|---|---|---|
| 0591-0395-00 | 00591039500 | 45460 TABLET in 1 BOX (0591-0395-00) | 45460 tablet | 16-SEP-15 | Current |