APTIDINE 75 - A P J Laboratories Limited

Manufacturer: A P J Laboratories Limited
Effective date: 2013-02-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:46:15

Label at a glance#

ProductAPTIDINE 75

Active ingredientRANITIDINE HYDROCHLORIDE

Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

RANITIDINE HYDROCHLORIDE

OTC - PURPOSE SECTION

Acid reducer

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over:

to relieve symptoms, swallow 1 tablet with a glass of water
to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
can be used up to twice daily (do not take more than 2 tablets in 24 hours)

children under 12 years: ask a doctor

INACTIVE INGREDIENT SECTION

CELLULOSE, MICROCRYSTALLINE

INACTIVE INGREDIENT SECTION

STARCH, CORN

INACTIVE INGREDIENT SECTION

POVIDONE K30

INACTIVE INGREDIENT SECTION

METHYLPARABEN

INACTIVE INGREDIENT SECTION

MAGNESIUM STEARATE

INACTIVE INGREDIENT SECTION

TALC

INACTIVE INGREDIENT SECTION

SODIUM STARCH GLYCOLATE TYPE A POTATO

INACTIVE INGREDIENT SECTION

SILICON DIOXIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
312773	ranitidine 75 MG Oral Tablet	PSN	1
312773	ranitidine 75 MG Oral Tablet	SCD	1
312773	ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
RANITIDINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7f54af34-be54-4c3c-894f-78df6452d747	Product name	3	20190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850	Product name	5	20190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7b	Product name	1	20180904
2f9d4e5c-e179-490e-8c43-f19e1e0ca228	Product name	1	20160720

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
46084-031-11	2019-11-27	C162847	48780-1	9855d018-eaf2-cd31-e053-dbdaa90ab51a	549c0a03-bce9-4c0f-8f60-e6964f63dce2
46084-031-12	2019-11-27	C162847	48780-1	9855d018-eaf2-cd31-e053-dbdaa90ab51a	549c0a03-bce9-4c0f-8f60-e6964f63dce2
46084-031-13	2019-11-27	C162847	48780-1	9855d018-eaf2-cd31-e053-dbdaa90ab51a	549c0a03-bce9-4c0f-8f60-e6964f63dce2
46084-031-14	2019-11-27	C162847	48780-1	9855d018-eaf2-cd31-e053-dbdaa90ab51a	549c0a03-bce9-4c0f-8f60-e6964f63dce2
46084-031-15	2019-11-27	C162847	48780-1	9855d018-eaf2-cd31-e053-dbdaa90ab51a	549c0a03-bce9-4c0f-8f60-e6964f63dce2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46084-031-11	APTIDINE75	5 in 1 BLISTER PACK	TABLET	5	1
46084-031-12	APTIDINE75	12 in 1 BLISTER PACK	TABLET	12	1
46084-031-13	APTIDINE75	36 in 1 BLISTER PACK	TABLET	36	1
46084-031-14	APTIDINE75	60 in 1 BLISTER PACK	TABLET	60	1
46084-031-15	APTIDINE75	120 in 1 BLISTER PACK	TABLET	120	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46084-031	APTIDINE 75 (RANITIDINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]	1	Legacy NDC, 5 package rows	20160609_549c0a03-bce9-4c0f-8f60-e6964f63dce2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

APTIDINE 75
RANITIDINE HYDROCHLORIDE
RANITIDINE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POVIDONE K30
METHYLPARABEN
MAGNESIUM STEARATE
TALC
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
46084-031	46084-031-15, 46084-031-14, 46084-031-13, 46084-031-12, 46084-031-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
RANITIDINE HYDROCHLORIDE	BK76465IHM	ACTIM
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
POVIDONE K30	U725QWY32X	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
TALC	7SEV7J4R1U	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075132-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL			2000-01-14

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075132-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-01-14	`f41ea6bd6efb…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cbc1050f-9b82-4e4c-aa84-78ba062e75b0			549c0a03-bce9-4c0f-8f60-e6964f63dce2	2013-02-21	Warnings	Exact identifier spl id: cbc1050f-9b82-4e4c-aa84-78ba062e75b0 spl set id: 549c0a03-bce9-4c0f-8f60-e6964f63dce2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.