Home NDC 0713-0536-12 PROMETHEGAN
Product NDC 0713-0536
Requested package NDC 0713-0536-12
11-digit product format 007130536
Labeler code 0713
Product ID 0713-0536_0b622b7b-a45f-eab0-e063-6394a90a0c0a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name promethazine hydrochloride
Dosage form SUPPOSITORY
Route RECTAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA040428
Marketing category ANDA
Marketing start 2004-02-28
Substance PROMETHAZINE HYDROCHLORIDE
Active strength 12.5 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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040428-001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 A040428-002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040428-001 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB RS 2002-02-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040428-002 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-03-31 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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 PROMETHEGAN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROMETHAZINE HYDROCHLORIDE 12.5 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992441 Internal RxNorm lookup 992445 Internal RxNorm lookup 992454 Internal RxNorm lookup 992459 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 0713-0536-10 PROMETHEGAN 1000 in 1 BOX SUPPOSITORY 1000 7 0713-0536-12 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 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 2 Promethazine ACTIVE MOIETY FF28EJQ494 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 2 Ascorbyl Palmitate INACTIVE INGREDIENT QN83US2B0N PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 2 Fat, Hard INACTIVE INGREDIENT 8334LX7S21 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 2 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 2 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 2 White Wax INACTIVE INGREDIENT 7G1J5DA97F PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0536 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20231201_5f079815-f48b-8b21-2130-7f791d967c9a.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 · 2 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 0713-0536-12 00713053612 12 SUPPOSITORY in 1 BOX (0713-0536-12) 12 suppository 2004-02-28 0000-00-00 No No Current