topcare heartburn relief 150

Product NDC: 36800-950
11-digit product format: 368000950
Labeler code: 36800
Product ID: 36800-950_ea9ee56b-1708-4f60-a169-a929f6873255
Type: HUMAN OTC DRUG
Nonproprietary name: Ranitidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA091429
Marketing category: ANDA
Marketing start: 2011-10-10
Marketing end: 2021-05-31
Substance: RANITIDINE HYDROCHLORIDE
Active strength: 150 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	36800-950		D	Discontinued by firm	2026-08-10
excluded package	package	36800-950	36800-950-05	D	Discontinued by firm	2026-08-10
excluded package	package	36800-950	36800-950-09	D	Discontinued by firm	2026-08-10
excluded package	package	36800-950	36800-950-62	D	Discontinued by firm	2026-08-10

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-950-62	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-950-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-950-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-950-62	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-950-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-950-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-950-62	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-950-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-950-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-950-62	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-950-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-950-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-950-62	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-950-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-950-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-950-62	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-950-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-950-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-950-62	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-950-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-950-09	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-950-62	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-950-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-950-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-950-62	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-950-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-950-09	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-950-62	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-950-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-950-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-950-62	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-950-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-950-09	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-950-62	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-950-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-950-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091429-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2011-05-11
A091429-002	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2011-05-11

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-950-09	EA - Each	36800-950	11e87456-9acd-4bff-8bbd-05e77eb2f504	1	2012-07-24
36800-950-62	EA - Each	36800-950	0284dcd9-506f-4821-a771-e0576c059cf7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	TOPCARE HEARTBURN RELIEF 150 (RANITIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	2
RANITIDINE	ACTIVE MOIETY	884KT10YB7	TOPCARE HEARTBURN RELIEF 150 (RANITIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPCARE HEARTBURN RELIEF 150 (RANITIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOPCARE HEARTBURN RELIEF 150 (RANITIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPCARE HEARTBURN RELIEF 150 (RANITIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	TOPCARE HEARTBURN RELIEF 150 (RANITIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPCARE HEARTBURN RELIEF 150 (RANITIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	TOPCARE HEARTBURN RELIEF 150 (RANITIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BK76465IHM	RANITIDINE HYDROCHLORIDE	66357-59-3	RANITIDINE HYDROCHLORIDE
884KT10YB7	RANITIDINE	66357-35-5	Ranitidine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-950-05	36800095005	32 BLISTER PACK in 1 CARTON (36800-950-05) > 1 TABLET, FILM COATED in 1 BLISTER PACK	32 blister pack	2012-03-12	0000-00-00	No	No	Current
36800-950-09	36800095009	1 BOTTLE in 1 CARTON (36800-950-09) > 65 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2011-11-25	0000-00-00	No	No	Current
36800-950-62	36800095062	24 BLISTER PACK in 1 CARTON (36800-950-62) > 1 TABLET, FILM COATED in 1 BLISTER PACK	24 blister pack	2011-10-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Heartburn Relief 150 Drug Facts	Topco Associates LLC	2021-05-10	HUMAN OTC DRUG LABEL	5