Home NDC 0713-0132 PROMETHEGAN
Product NDC 0713-0132
11-digit product format 007130132
Labeler code 0713
Product ID 0713-0132_0b625ebc-4f41-49d9-e063-6294a90a56ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name promethazine hydrochloride
Dosage form SUPPOSITORY
Route RECTAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA087165
Marketing category ANDA
Marketing start 1987-08-31
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 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 A087165-001 PROMETHEGAN PROMETHAZINE HYDROCHLORIDE 50MG SUPPOSITORY / RECTAL RS 1987-08-14
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 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base PROMETHEGAN
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 992478 Internal RxNorm lookup 992481 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0713-0132-10 PROMETHEGAN 1000 in 1 BOX SUPPOSITORY 1000 7 0713-0132-12 PROMETHEGAN 12 in 1 BOX SUPPOSITORY 12 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Promethazine Hydrochloride ACTIVE INGREDIENT R61ZEH7I1I PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 3 Promethazine Hydrochloride ACTIVE INGREDIENT R61ZEH7I1I PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 3 Promethazine ACTIVE MOIETY FF28EJQ494 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 3 Promethazine ACTIVE MOIETY FF28EJQ494 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 3 Ascorbyl Palmitate INACTIVE INGREDIENT QN83US2B0N PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 3 Ascorbyl palmitate INACTIVE INGREDIENT QN83US2B0N PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 3 Fat, Hard INACTIVE INGREDIENT 8334LX7S21 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 3 Fat, Hard INACTIVE INGREDIENT 8334LX7S21 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 3 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 3 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0132 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20231201_636bb9bc-0cc5-4d6a-85be-6471acf01ffc.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 Marketing end Sample Exclude flag Status 0713-0132-10 00713013210 1000 SUPPOSITORY in 1 BOX (0713-0132-10) 1000 suppository 1987-08-31 0000-00-00 No No Current 0713-0132-12 00713013212 12 SUPPOSITORY in 1 BOX (0713-0132-12) 12 suppository 1987-08-31 0000-00-00 No No Current