Home NDC 0591-5319-00 Promethazine Hydrochloride
Product NDC 0591-5319
Requested package NDC 0591-5319-00
11-digit product format 005915319
Labeler code 0591
Product ID 0591-5319_4ad005c9-31b6-4232-995f-920d1839256e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA083711
Marketing category ANDA
Marketing start 1973-09-21
Substance PROMETHAZINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Historic NDC status page 1 of 1 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A083711-001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A083711-001 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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A083711-001 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB Approved before 1982 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Promethazine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROMETHAZINE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R61ZEH7I1I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992447 Internal RxNorm lookup 992475 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-5319-01 Promethazine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET 100 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROMETHAZINE HYDROCHLORIDE ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 4 PROMETHAZINE ACTIVE MOIETY FF28EJQ494 PROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 4 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP PROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PROMETHAZINE HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-5319 PROMETHAZINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20240207_a32255f0-0077-489e-bdc6-869aca8cd434.zip
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 0591-5319-00 00591531900 32000 TABLET in 1 BAG (0591-5319-00) 32000 tablet 21-SEP-73 Current