Progesterone NDC 43598-349

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-349Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0349Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
43598-349-01	43598034901	100 CAPSULE in 1 BOTTLE (43598-349-01)Marketed from Mar 25, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Progesterone
Generic name (nonproprietary): progesterone
Active ingredients: Progesterone — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Dr. Reddys Laboratories, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208801
Marketing start: Mar 25, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Progesterone (Chemical structure)
Identifiers: Product ID 43598-349_4b8f3d16-f096-32f0-65f9-230ab8c292b7SPL ID 4b8f3d16-f096-32f0-65f9-230ab8c292b7SPL set ID efded380-02ff-68c9-13e4-47a561ede440RxCUI 260243, 312641UNII 4G7DS2Q64Y
Pharmacologic class: Progesterone

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N443598034901 followed by a unit qualifier and the quantity

Package 43598-0349-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 5, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Progesterone Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208801

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208801
Product	Strength	Form · route	Labeler	Product NDC
Progesterone	Progesterone 200 mg/1	CapsuleOral	Dr. Reddys Laboratories, Inc.	43598-350